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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2005 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals

This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.


Tradename/
Established Name
Indication for Use NDA Number Applicant Approval Date
MacoProductions S.A.S. CPD/AS-1: MacoPharma Leucoflex MTL1 Leukoreduction System for Blood Components known as MTL1-WB
Anticoagulant Citrate Phosphate Dextrose Solution (CPD)
For pre-storage leukocyte reduction of whole blood initiated between 4 and 7 hours after collection if whole blood is stored at ambient temperature, or between 4 and 8 hours of storage at 1 to 6°C BN040083 MacoProductions S.A.S.
2335 Massey Lane
Decatur, GA 30033
11/21/2005